Nystatin Tablets, USP Rx only

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Contacts and useful links#

PhoneLabel contact1-888-838-2872

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.govwww.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

C₄₇H₇₅NO₁₇ M.W. 926.13

Nystatin tablets, USP contain the inactive ingredients: corn starch, povidone, compressible sugar, microcrystalline cellulose, sodium starch glycolate, talc, magnesium stearate, purified water, and coloring.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

SPL UNCLASSIFIED SECTION

Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology

SPL UNCLASSIFIED SECTION

Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

SPL UNCLASSIFIED SECTION

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

SPL UNCLASSIFIED SECTION

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

SPL UNCLASSIFIED SECTION

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

OVERDOSAGE SECTION

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin tablets USP, 500,000 units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets
(NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

Keep this and all medications out of the reach of children.

Manufactured In Canada By:
Teva Canada Limited
Toronto, Canada M1B 2K9

Manufactured For:
Teva Pharmaceuticals
 Parsippany, NJ 07054

Rev. O 11/2022

Package/Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-0983-01
Nystatin Tablets, USP
500,000 units (oral)
Rx only
100 Tablets

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Products#

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• Nystatin
• STARCH, CORN
• POVIDONE K30
• SUCROSE
• MALTODEXTRIN
• CELLULOSE, MICROCRYSTALLINE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TALC
• MAGNESIUM STEARATE
• WATER

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